Semi-barbed Suture for Pulmonary Small Nodules Localization

A Clinical Application Study of a CT Guided Small Pulmonary Nodule Puncture and Positioning Device Based on Pre-filled Absorbable Semi-barbed Wire

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04168359

Enrollment

Registered

2019-11-19

Start date

2019-12-09

Completion date

2021-03-02

Last updated

2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nodule, Solitary Pulmonary, Suture, Video-Assisted Thoracoscopic Surgery

Brief summary

Hookwire and microcoil are currently the most widely used localization instruments. Although their success rate is relatively high in preoperative localization attempts, they may lead to consequences that negatively affect patient outcomes, such as pain because of the metal's hardness, localization failure due to wire detachment, and the presence of permanent traces of metal and foreign bodies . To overcome these disadvantages, we designed an absorbable semi-barbed suture to localize small intrapulmonary nodules (patent number: ZL201821444387.X). The results of the previous animal experiments were satisfactory, and it is now necessary to recruit 10 patients for clinical trials.

Interventions

DEVICEabsorbable semi-barbed suture

Positioning the intrapulmonary nodules of patient in this group with a absorbable semi-barbed suture positioning device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

1. solid nodules with a diameter2cm and distance to visceral pleura 0.5cm； 2. GGN； 3. part-solid GGN, with a solid portion1cm and distance to the visceral pleura 1cm； 4. Patients with nodules at a deep location, who underwent localization to facilitate localization in the resected specimen by a pathologist

Exclusion criteria

1. The lesion site is not suitable for percutaneous lung puncture; 2. those who have pneumothorax and pleural effusion; 3. Poor general condition, severe damage to cardiopulmonary function, cachexia, and inability to tolerate surgery; 4. Those who refuse surgery; 5. Those who did not sign the informed consent form.

Design outcomes

Primary

Measure	Time frame	Description
Success rate	half an hour after locating	Successfully located around the small nodules in the lungs, no dislocation occurred

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026